Pressure regulators for use with medical gases – Part 1: Pressure regulators and pressure regulators with flow-metering devices (ISO 10524-1:2006)
DIN EN ISO 10524-1:2006-05 (E)
Pressure regulators for use with medical gases – Part 1: Pressure regulators and
pressure regulators with flow-metering dev ices (ISO 10524-1:2006)
Contents Page
Foreword ……………………………………………………………………………………………………………………………………….2
Introduction ……………………………………………………………………………………………………………………………………4
1 Scope ……………………………………………………………………………………………………………………………..5
2 Normative references ……………………………………………………………………………………………………..6
3 Terms and definitions ……………………………………………………………………………………………………..6
4 Nomenclature …………………………………………………………………………………………………………………8
5 General requirements ……………………………………………………………………………………………………..8
5.1 Safety ……………………………………………………………………………………………………………………………..8
5.2 Alternative construction ………………………………………………………………………………………………….8
5.3 Materials …………………………………………………………………………………………………………………………8
5.4 Design requirements ……………………………………………………………………………………………………….9
5.5 Constructional requirements …………………………………………………………………………………………16
6 Test methods ………………………………………………………………………………………………………………..16
6.1 General …………………………………………………………………………………………………………………………16
6.2 Test methods for outlet pressure …………………………………………………………………………………..17
6.3 Test method for pressure-relief valve …………………………………………………………………………….18
6.4 Test methods for leakage ………………………………………………………………………………………………18
6.5 Test method for mechanical strength …………………………………………………………………………….19
6.6 Test method for resistance to ignition ……………………………………………………………………………19
6.7 Test method for accuracy of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………20
6.8 Test method for the stability of flow of pressure regulators fitted with flowmeters or
flowgauges ……………………………………………………………………………………………………………………20
6.9 Test method for stability and accuracy of flow of pressure regulators fitted with fixed
orifices ………………………………………………………………………………………………………………………….20
6.10 Test method for flow setting and loosening torques ………………………………………………………20
6.11 Test method for durability of markings and colour coding ……………………………………………..20
7 Marking, colour coding, packaging ………………………………………………………………………………..20
7.1 Marking …………………………………………………………………………………………………………………………20
7.2 Colour coding ……………………………………………………………………………………………………………….22
7.3 Packaging …………………………………………………………………………………………………………………….22
8 Information to be supplied by the manufacturer …………………………………………………………….22
Annex A (informative) Typical examples of pressure regulators and pressure regulators with flowmetering
devices …………………………………………………………………………………………………………..26
Annex B (informative) Rationale ……………………………………………………………………………………………………30
Annex C (informative) Reported regional and national deviations of colour coding and
nomenclature for medical gases ……………………………………………………………………………………32
Bibliography …………………………………………………………………………………………………………………………………34
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42 EEC concerning Medical Devices ………………………….. 35